XableCath Support Catheter Product Family

K180986 · Xablecath, Inc. · DQY · May 15, 2018 · Cardiovascular

Device Facts

• Record ID: K180986
• Device Name: XableCath Support Catheter Product Family
• Applicant: Xablecath, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 15, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices.

Device Story

XableCath Support Catheter is a percutaneous, single-lumen, over-the-wire (OTW) catheter used in peripheral vasculature. It facilitates guidewire placement and exchange during interventional procedures. The device features an abrasion-resistant distal tip (cobalt-chromium alloy) designed to navigate complex arterial segments. It is operated by physicians in hospital or surgical suite settings under fluoroscopic guidance. The catheter is inserted over a steerable guidewire; the physician advances it to the target lesion or vessel segment. The device provides a stable platform for exchanging interventional tools. By enabling safe access to discrete vascular regions, it assists in treating peripheral artery disease (PAD). The device is single-use and sterile.

Clinical Evidence

Clinical validation involved 26 patients (mean age 69, 77% male) with PAD undergoing lower extremity angiography. 27 catheters were used to traverse 80 arterial segments. Primary endpoints focused on procedural safety and passage adequacy. Results showed no procedural complications attributable to the device; one minor dissection occurred due to subsequent balloon angioplasty. No thrombosis, rupture, or embolization occurred. Follow-up at mean 53 days showed no device-related complications.

Technological Characteristics

Single-lumen catheter; Nylon shaft; HDPE proximal hub; Olefin strain relief; Cobalt-chromium alloy distal tip (abrasion configuration); Cobalt-chromium/SS markers. Sterilized via Gamma radiation (SAL 10^-6). Complies with ISO 10555-1. Burst strength ≥300 psi. OTW manual deployment.

Indications for Use

Indicated for patients requiring peripheral vascular access for guidewire placement and exchange. No specific age or gender contraindications noted.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• XableCath Support Catheter (K170041)

Submission Summary (Full Text)

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May 15, 2018

XableCath, Inc. Mr. Rick Gaykowski Chief Regulatory Officer 417 South Wakara Way, Suite 3510 Salt Lake City, Utah 84108-1457

Re: K180986

Trade/Device Name: XableCath Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 7, 2018 Received: April 16, 2018

Dear Mr. Gaykowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180986

Device Name XableCath Support Catheter

Indications for Use (Describe)

The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices.

Type of Use (Select one or both, as applicable)

| <span style="font-family: DejaVu Sans, sans-serif;">✘</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|

| X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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K180986

XableCath

Special 510(k) Special 510(k)
XableCath™ Support Catheter

# 510(k) SUMMARY XableCath™ Support Catheter

| Submitter Information [21 CFR 807.929(a)(1)] | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | XableCath, Inc. | | |
| Address | 417 S Wakara Way, Suite 3510<br>Salt Lake City, UT 84108-1457<br>USA | | |
| Phone number | 617-447-4000 Mobile | | |
| Fax number | N/A | | |
| Establishment<br>Registration Number | Yet to be secured | | |
| Name of contact<br>person(s) | Rick Gaykowski, Chief Regulatory Officer, Primary<br>Lisa Dunlea, Pres/CEO, Secondary | | |
| Date prepared | April 7, 2018 | | |
| Name of the device [21 CFR 807.92(a)(2)] | | | |
| Trade or proprietary<br>name | XableCath Support Catheter | | |
| Common or usual<br>name | Peripheral Vascular Support Catheter | | |
| Classification name | Class II | | |
| Regulation | 21 CFR 870.1250 | | |
| Product Code(s) | DQY | | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed<br>[21 CFR 807.92(a)(3)] | XableCath Support Catheter, cleared under 510(k) K170041 | | |
| Device description<br>[21 CFR 807.92(a)(4)] | Catheter, Percutaneous | | |
| Indications for use<br>[21 CFR 807.92(a)(5)] | The XableCath catheter is intended to be used to facilitate access to discrete<br>regions of the peripheral vasculature in conjunction with steerable guidewires.<br>This device may be used to facilitate placement and exchange of guidewires and<br>other interventional devices. | | |
| Summary of the technological characteristics of the device compared to the predicate device<br>[21 CFR 807.92(a)(6)] | | | |
| Feature | Subject Device: XableCath Support<br>Catheter | | |
| | Predicate Device: XableCath Support<br>Catheter | | |
| Proximal Luer/Hub | HDPE | | |
| | HDPE | | |
| Strain Relief | Olefin | Olefin | |
| Catheter Shaft | Nylon, Single lumen | Nylon, Single lumen | |
| Markers | Cobalt-chromium/SS | Cobalt-chromium/SS | |
| Distal Tip | Abrasion | Blunt | |
| Distal Tip Material | Cobalt chromium alloy | Cobalt chromium alloy | |
| Coating | N/A | N/A | |
| Infusion<br>Pressure/Burst<br>Strength | ≥300 psi | ≥300 psi | |
| | Outer Diameter | Varies by Model<br>Proximal: 0.043", 0.053", 0.062"<br>Distal: 0.060", 0.070", 0.080"<br>Tip: 0.052", 0.063", 0.071 | Varies by Model<br>Proximal: 0.043", 0.053", 0.062"<br>Distal: 0.060", 0.070", 0.080"<br>Tip: 0.052", 0.063", 0.071 |
| | | Guidewire<br>Compatibility | 0.014", 0.018", 0.035" |
| Guide Catheter (max) | | | ≥4Fr |
| Access Sheath (max) | ≥4Fr | ≥4Fr | |
| Effective Working<br>Length | 65, 90, 145cm | 65, 90, 145cm | |
| | Deployment | OTW - Manual | OTW - Manual |
| Sterilization Method | Gamma<br>(SAL - 10-6) | Gamma<br>(SAL - 10-6) | |
| | Single Use, Sterile | Yes | Yes |
| Labeling | Individual IFU: Warning, Cautions,<br>Contraindications, tables, images,<br>organized outline. | Individual IFU: Warning, Cautions,<br>Contraindications, tables, images,<br>organized outline. | |
| | Packaging | Sterile thermal sealed Tyvek/PET<br>Pouch, SBS Carton | Sterile thermal sealed Tyvek/PET<br>Pouch, SBS Carton |
| Use Environment | | Rx Only - By or on the order of a<br>physician. Hospital, Lab/Surgical<br>Suite | Rx Only - By or on the order of a<br>physician. Hospital, Lab/Surgical<br>Suite |
| | Performance Testing | ISO 10555-1 Second Edition 2013-<br>07-01. Intravascular catheters --<br>Sterile, single-use intravascular<br>catheters -- Part 1: General<br>Requirements | ISO 10555-1 Second Edition 2013-<br>07-01. Intravascular catheters --<br>Sterile, single-use intravascular<br>catheters -- Part 1: General<br>Requirements |
| Indications for Use | | The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices. | The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices. |
| Performance Data [21 CFR 807.92(b)] | | | |
| Summary of non-clinical tests conducted for determination of substantial equivalence<br>[21 CFR 807.92(b)(1)] | | | |
| As required by the risk analysis, the following verification tests have been conducted on the XableCath Support Catheter (please refer to Section 17 for additional information): | | | |
| Direct product bench <i>in-vitro</i> comparison testing has shown the subject & predicate products to be equivalent, via assessment within the following areas: | | | |
| Visual & technical inspections Luer syringe compatibility Sheath compatibility Guidewire retraction/reinsertion Relative radiopacity comparison Torque transmission & capability Simulated use (iliac model) | | Dimensional assessment & comparisons Guidewire compatibility Leak Testing Catheter kink-resistance Tensile testing (proximal & distal) Corrosion testing General packaging, shelf-life/expiry | |
| Full panel biocompatibility was successfully performed in accord with product classification, under GLP rigors, demonstrating that all utilized materials and methods of construction/processing passed biocompatibility rigors. Conducted test included: | | | |
| Cytotoxicity Irritation/Intracutaneous Hemolysis Complement Activation Platelet and Leukocyte Count | Sensitization Reactivity Systemic…